Journal of shoulder and elbow surgery
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J Shoulder Elbow Surg · Dec 2019
The fragility of findings of randomized controlled trials in shoulder and elbow surgery.
Considered the gold standard of study designs, randomized controlled trials' (RCTs) results shape clinical practice, effect policy, and influence reimbursement. The fragility index (FI) can be used to quantitate the relative robustness of RCT results, with higher scores indicating more stout results. Unfortunately, most RCTs in surgery have fragile results. The aim of this study was to report on the FI in addition to a qualitative assessment of recent RCTs within the field of shoulder and elbow surgery. ⋯ The median FI reported in the recent shoulder/elbow literature is 4; however, a high proportion of included RCTs display significant methodological concerns. The FI is a useful adjunct to analyze RCT results, but careful analysis of trial methods should be employed in each circumstance before drawing conclusions.